Software in Medical Devices, by MD101 Consulting

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Templates

Templates files for software development of medical devices.

These files are under the creative commons CC-BY-ND license.

Please, read the license before any use. 

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Friday, 8 March 2024

Templates: Security Risk Management Plan and Security Risk Assessment Report

Cybersecurity guidances and standards have quite evolved the last few months.
It's time to push new templates!

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Saturday, 30 November 2019

Template: Verification Validation Transfer Review Report

The final validation was missing in the list on templates on this blog. Problem solved.

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Monday, 15 October 2018

Cybersecurity - Part 5 Templates

Hi there! Long time no see once again. I dig up our series of posts on cybersecurity.
In this post I publish two new templates for cybersecurity risk management.

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Wednesday, 18 April 2018

Update of SRS and SAD templates for GDPR

European Regulation 2016/679, aka GDPR, will be fully in force in May 2018. Everybody knowns that we have something to do to be compliant since it has been published. And everybody is getting awake only two months before the full application. So do I.

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Friday, 25 April 2014

Template repository updated: Software Development Tool Validation Plan

Template!
Here is a new template: the Software Development Tool Validation Plan.

It is made for validation of software development tools, as seen in the previous series of posts.

It is very similar to the all-in-one template but with a major difference: it contains sections and comments to help validating software not internally developed, like software bought to a vendor or open-source software.

It doesn't contain the risk management data. They shall remain in the dedicated templates: Risk management plan and Risk analysis report.

More templates on my templates repository page.

Please, feel free to give me feedback on my e-mail contact@cm-dm.com

I share this template with the conditions of CC-BY-NC-ND license.



Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 France License.

Friday, 18 October 2013

Template: new Software Configuration Management Plan

A new Software Configuration Management Plan (SCMP) Template, more adapted to agile methods.

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Friday, 4 October 2013

Template: Risk Matrix Calculator

Risk matrixes are a useful way to show graphically the ranges in which risks are acceptable, tolerable and unacceptable. Here is an excel sheet that automates the computation of ranges.

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Friday, 20 September 2013

Templates Risk Management Plan and Risk Analysis Report updated

Here is an update of Risk Management Plan and Risk Analysis Report templates.

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Friday, 13 September 2013

Templates STP - STD and STR updated

Here is an update of Software Test Plan, Software Test Description, and Software Test Report templates.

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Friday, 6 September 2013

Templates SAD and SDD updated

Here is an update of System Architecture Description template and Software Detailed Design template.

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Friday, 30 August 2013

Template SRS updated

Here is an update of Software Requirements Specifications template.

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Friday, 17 August 2012

Three templates

I've already posted a long list of templates on this blog. You can find them on the templates repository page.
There are templates for big projects, with one or more templates for every phase of a software development project. And there is the all-in-one template for very simple projects. This list lacks templates for simple projects that deserve more than a single document.
Here are the three templates:

  1. Software Development Management
  2. Software Specifications and Conception
  3. Software Verification and Tests

The advantage of this list is to have multiple specification conception and tests phases. The management template is filled at the beginning of the project. The Specification and Conception template is filled and updated each time these artifacts change. And the tests template is filled during each tests phase. They fit simple to middle size projects:

  • Project timeline of 1 year
  • Team of 4 developers
  • Simple architecture (standalone or client-server)

They don't contain the risk management data. They shall remain in the dedicated templates: Risk management plan and risk analysis report.

More templates on my templates repository page.

Please, feel free to give me feedback on my e-mail contact@cm-dm.com

I share this template with the conditions of CC-BY-NC-ND license.



Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 France License.

Friday, 3 August 2012

How to use templates with agile methods?

All templates I have written are listed in my templates repository page. I already explained in that page and some other articles how to use them with waterfall development process.
But their use is not obvious with agile methods. Here are a few explanations.

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Friday, 27 July 2012

Template: All-in-one

Template!
Here is a new template: the all-in-one template for software development process.
It is made for simple software development project where everything can be put in only one document. Especially, there is room for only one verification phase in the template. this is a deliberate situation. If you plan to have more than a single phase of verification, you should use other templates (link on template repository page below at the end of this post).
It contains simple and reduced parts of:

  1. Project management plan,
  2. Software Requirements Specifications,
  3. System Architecture Document,
  4. Software Tests Plan, Description and Report.


It doesn't contain the risk management data. They shall remain in the dedicated templates: Risk management plan and Risk analysis report.

More templates on my templates repository page.

Please, feel free to give me feedback on my e-mail contact@cm-dm.com

I share this template with the conditions of CC-BY-NC-ND license.



Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 France License.

Friday, 20 July 2012

Where do these templates come from?

Perhaps some of you who download my templates wonder how I managed to write them or where they come from.
This is a long story. Once upon a time in 1940’s, Bell Labs scientists John Bardeen, Walter Brattain and William Schockley invented the transistor.
Well, huh, not so long!

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Friday, 4 May 2012

Template: User Guide

Hello,

Back on my blog after a few days off. I wrote in my post about classes of software that I would release a template on user guide. Here it is!

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Friday, 23 March 2012

Template: Usability Specification Document

After the Risk Managment Plan template, here is the Usability Specification Document.

The Usability Specification Document is your companion during the phases where you define the graphical user interface and ergonomics of your software.

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Friday, 9 March 2012

Template: Risk Management Plan

At last, here is the Risk Management Plan Template.

The risk management plan was missing in my list of templates. Error repaired! It is tailor made for software medical devices. So you'll find some stuff specific to software, with references to IEC/TR 80002-1 and IEC 62304.

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Wednesday, 29 February 2012

Templates: software development plan and software configuration management plan

Here are the Software Development Plan Template and the Software Configuration Management Plan Template

These templates are technical ones. But they are closely linked to project management hence they contain sections about reponsibilities.

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Friday, 17 February 2012

Template: Version Description Document

In Software-Requirements-Specifications, I put everything you need to deal with technical requirements of your software.

In Software-Detailed-Design, I put everything about the design description of packages and component inside software, their interfaces and their workflows.

In System Architecture Description, I put everything about the description of the whole architecture of system and software.

In Software Test Plan, Software Test Description and Software Test Report I gathered all information about the organization of tests, the traceability with SRS requirements, the description and results of tests.

The Version Description Document is about the description of a delivery of software and hardware. If contains the mandatory information to identify a software version, its dependencies and how it is generated.

This template is the last of my first series of templates. You have all you need to document a software development project of middle importance for a medical device.

However the Project Management Plan template is made for simple projects. For a project with more complexity, you need to pay more attention to software configuration and software development.

The next two templates will be the software configuration management plan and the software development plan. They will contain more information on these subjects than what you find in the project management plan.
Later on, I will add a risk management plan to the templates. Then, the series of management templates will be complete.

Stay tuned, my list of templates is growing fast!

I gather all my templates on the templates page. You'll find them all there.

Please, feel free to give me feedback on my e-mail contact@cm-dm.com

I share this template with the conditions of CC-BY-NC-ND license.



Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 France License.

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